Kornimate/medical-research-clean huggingface dataset:
venetoclax, lenalidomide and rituximab in patients with previously untreated mantle cell lymphoma

Conditions: Mantle Cell Lymphoma

Summary: the purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with mantle cell lymphoma (mcl).


Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of mantle cell lymphoma (mcl) established by histologic assessment * laboratory, radiographic, physical exam findings and/or symptoms attributable to mcl * ecog performance status (eastern cooperative oncology group performance status: an attempt to quantify cancer patients' general well-being and activities of daily life. the score ranges from 0 to 5 where 0 is asymptomatic and 5 is death) less or equal to 2 * all study participants must be registered into the mandatory revlimid rems® program, and be willing and able to comply with the requirements of the rems® program * females of reproductive potential must adhere to the scheduled pregnancy testing as required in the revlimid rems® program. * men and women of childbearing potential on appropriate contraception * adequate organ function * ability to understand and the willingness to sign a written informed consent. * ability to swallow oral capsules/tablets exclusion criteria: * prior treatment for mcl with chemotherapy * pregnant or breastfeeding women * grade 2 or higher peripheral neuropathy * known history of cns (central nervous system) or leptomeningeal by mcl prior to study enrollment * significant cardiovascular disease * any condition that might significantly impair drug absorption as determined by the investigator * uncontrolled active systemic fungal, bacterial, viral, or other infection, or intravenous anti-infective treatment within 2 weeks before first dose of study drug * history of stroke or intracranial hemorrhage within 6 months of 1st dose of study drug * concurrent participation in another clinical trial * subject has received a moderate or strong cyp3a inhibitor or inducer within 1 week prior to treatment initiation. * psychiatric illness or social situations that would limit compliance with study requirements * subject has known positivity to hiv * active infection with hepatitis b or c virus as determined by a detectable viral load on pcr. * prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to\< 2 years.
local infiltration analgesia following total knee arthroplasty

Conditions: Postoperative Pain

Summary: the primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. secondary end-points are hospital stay, pain intensity and side effects. in an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

postoperative pain is often severe following knee arthroplasty. recently, a local infiltration analgesia (lia) technique was developed by drs kerr and kohan in sydney, australia. with this lia-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively. we ahve completed a study on unicompartmental knee arthroplasty and the present study is investigating total knee arthroplasties. the primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. secondary end-points are hospital stay, pain intensity and side effects. in an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

Eligibility criteria:
inclusion criteria: * patients scheduled for total knee arthroplasty * aged 20-85 yrs * asa physical status i-iii and mobility indicating normal postoperative mobilization exclusion criteria: * known allergy or intolerance to one of the study drugs * serious liver-, heart- or renal decease * rheumatoid arthritis * chronic pain or bleeding disorder

Keywords: postoperative pain local infiltration analgesia knee arthroplasty
registry study of t cell depleted allo non-myeloablative stem cell transplant

Conditions: Hodgkin's Disease; Non Hodgkin's Lymphoma; Myeloma; Leukemia; Myelodysplasia

Summary: allogeneic transplantation is used to treat many malignant and non-malignant diseases. the investigators and others have shown that less toxic preparative regimens (reduced intensity or 'mini' transplants) allow reliable allogeneic engraftment and durable remissions, significantly broadening the population of patients who may be offered this therapy to those who are older and more infirmed. the field is now focusing on the period post transplant for approaches to immune recovery leading to improved outcomes. the primary objective of this registry is to catalogue data from patients who undergo standard of care reduced intensity allogeneic transplantation.

subjects will have toxicity monitored and reported per the center for international blood and marrow transplant research (cibmtr) program standard and as required by law for bone marrow transplant (bmt) reporting in the usa. data will be collected from physical exam, laboratory studies, radiographs that are performed for clinical purposes. the tests and procedures are not in addition or in excess of our standards for allogeneic transplant outside of this registry. data about donors will also be collected.

Eligibility criteria:
recipient inclusion criteria: * subjects ≥ 18 years of age undergoing a reduced intensity allogeneic transplant exclusion criteria: * subjects \< 18 years of age * subjects not undergoing nonmyeloablative or ablative allogeneic transplant

Keywords: stem cell transplantation, non-myeloablative
a study of the safety of gabapentin in a potential over-the-counter population with occasional sleeplessness

Conditions: Transient Insomnia

Summary: the purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness


Eligibility criteria:
inclusion criteria: * subjects \>/= 12 years of age who reported occasional sleeplessness in month prior to screening exclusion criteria: * females who were pregnant or breastfeeding
safety and efficacy of tuly (rasburicase) in prevention and treatment of malignancy-associated hyperuricemia

Conditions: Hyperuricemia

Summary: this study is a prospective, open-label, multicentre study. hundred eligible patients with stage iii or iv non-hodgkin lymphoma (nhl) or acute lymphoblastic leukemia (all) with a peripheral white blood cell (wbc) count of \> 25,000/µl or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dl will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. the primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid auc 0-96 hr and incidence of adverse events will be assessed during 11 days study period.

all eligible patients will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. the primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid auc 0-96 hr and incidence of adverse events will be assessed during 11 days study period.

Eligibility criteria:
inclusion criteria: 1. patients of both genders aged between 1 to 75 years; 2. patients with stage iii or iv non-hodgkin lymphoma (nhl) or acute lymphoblastic leukemia (all) with a peripheral wbc count of \>25,000/µl or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dl; 3. eastern cooperative oncology group (ecog) performance scale of ≤3; 4. patients scheduled to receive chemotherapy. exclusion criteria: 1. patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions; 2. pregnant and lactating; 3. patients with glucose-6-phosphate dehydrogenase deficiency; 4. exposure to rasburicase or allopurinol within 7 days; 5. history of psychiatric or co-morbid unstable medical conditions
a study to reveal the patient characteristics and treatment patterns of stage iii non-small-cell lung cancer patients

Conditions: Non-small-cell Lung Cancer (NSCLC)

Summary: this large multinational, non-interventional study (nis), will retrospectively collect data derived from established medical records over a period of up to approximately 6 years (2013 to 2018), building a platform to capture and consolidate information on treatment patterns, overall survival (os) and treatment effectiveness outcomes in the real-world setting.

this is multi-centre, multicountry, longitudinal cohort of patients with primary stage iii nsclc (non-small cell lung cancer), identified through the review of established patient medical records. patients diagnosed with primary stage iii nsclc between 01 january 2013 and 31 december 2017 will be targeted for study inclusion, allowing at least 9 months of follow-up for living patients recruited at last day of the enrolment window. it is estimated that a total of approx. 2000 patients from 15-20 countries (approax.) patients' demographic and clinical characteristics and treatment patterns will be described. clinical outcomes such as progression-free survival (pfs), time to progression (ttp), objective response rate (orr) and disease control rate (dcr) will be described by line of therapy (lot). overall survival will be described, where available. healthcare resource utilisation will be described, as available from medical records.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted), according to local regulations 2. adult male or female (≥18 years old or according to age of majority as defined by local regulations) 3. first ever diagnosis of lung cancer (absence of previous diagnosis of lung cancer, including small cell lung cancer \[sclc\] and nsclc) in the patient's medical records 4. primary diagnosis of stage iii nsclc, confirmed by pathology, between 01 january 2013 and 31 december 2017 5. available medical records exclusion criteria: 1. patients with a concomitant cancer at the time of diagnosis of stage iii nsclc, except for non-metastatic non-melanoma skin cancers or in situ or benign neoplasms. a cancer will be considered concomitant if it occurs within 5 years of nsclc diagnosis 2. patients initially diagnosed with stage i-ii nsclc who have progressed to stage iii

Keywords: lung cancer
somatostatin analog treatment of acromegaly before pituitary surgery : comparison with neurosurgery alone

Conditions: Acromegaly

Summary: the aim of the study is to evaluate the interest of a six month pre-operative treatment with a long-acting somatostatin analog (sandostatin lp) versus surgery alone in patients with a pituitary adenoma responsible for acromegaly.

somatotroph pituitary adenoma is the most frequent cause of acromegaly. a transsphenoidal removal of the tumor is used as the first line treatment. somatostatin analogs are used as to whether recovery was not obtained after surgery or pituitary surgery was contraindicated. previous studies with somatostatin analogs have shown a drop in plasma gh and igf-1 levels and a reduction in adenoma size in 75 and 25% of patients respectively. retrospective studies suggest that a treatment with somatostatin analogs performed before surgery may be of interest to improve anesthesic conditions and surgical outcome. the aim of present study is to prospectively evaluate the interest of a first line treatment with a long-acting somatostatin analog (sandostatin) before performing a pituitary surgery in acromegalic patients with either a micro or a macroadenoma to improve peri-operative conditions and hopefully surgical outcome. after informed consent, untreated acromegalic patients will be included and randomly assigned to one of the following treatment procedures : either pituitary surgery or a six month treatment with long-acting sandostatin 30 mg monthly for 6 months before performing transsphenoïdal adenoma removal. the patients will be evaluated before any treatment, on months 3 and 6 of the treatment with sandostatin (for the patients enrolled in this arm of the study) and on months 3 and 12 after pituitary neurosurgery. each evaluation will include clinical data, hormone testing and radiological (mri) investigation. the main endpoint will be the rate of recovery proved by a normalisation of gh secretion and plasma igf-1 level. secondary endpoints will include the evaluation of clinical, radiological, biological, anesthesic, surgical and pathological parameters. a comparison between the two arms will be performed at entry into the study, at the time of surgery and then on months 3 and 12 following the transsphenoidal removal of the somatotroph adenoma.

Eligibility criteria:
inclusion criteria: * men and women * 18-80 years old * untreated acromegaly * unsuppressed gh secretion after a glucose load and elevated igf-1 plasma levels * presence of a pituitary adenoma on mri * informed consent given. exclusion criteria: * acromegaly previously treated * contraindication to pituitary surgery * associated hyperprolactinemia above 200 ng/ml * visual field defect needing rapid transsphenoidal surgery * contraindication to a treatment with octreotide

Keywords: acromegaly pituitary adenoma octreotide transsphenoïdal surgery gh igf-1
cardiac rehabilitation after pacemaker implantation

Conditions: Bradycardia; Pacemaker

Summary: the investigators assessed whether short-term cardiac rehabilitation following pacemaker implantation was enough to improve both physical function and quality of life.

exercise-based cardiac rehabilitation (cr) improves clinical outcomes in patients with cardiovascular diseases. however, few data exist regarding the role of early short-term cr in patients undergoing pacemaker (pm) implantation. the investigators assessed whether short-term cr following pm implantation was enough to improve both physical function and quality of life (qol).

Eligibility criteria:
inclusion criteria: * patients who were scheduled to undergo new pm implantation exclusion criteria: * patients older than 75 years * patients who are contraindicated to exercise * patients who refuse to participate
immediate effects of open and closed kinetic chain exercises on upper extremity in stroke patients.

Conditions: Stroke

Summary: stroke is a sudden disruption of blood flow to the brain, resulting in physical and mental disabilities. it's a global health issue affecting millions each year, often leading to paralysis, altered muscle tone, and loss of motor control and balance. this study aims to examine the immediate effects of open and closed kinetic chain activites on upper extremity spasticity and motor dexterity in hemiplegic patients. this study will be conducted simultaneously at i̇stinye university hospital medical park gaziosmanpaşa and i̇stinye university physiotherapy and rehabilitation application and research center (i̇süfi̇zyotem). 50 stroke patients will be included in the study, and all participants will be asked to sign an informed consent form. at the beginning of the session, all participants will be evaluated for their socio-demographic characteristics by a questionnaire created by the researchers, muscle viscoelastic properties by myotonpro, upper extremity muscle tone by modified ashworth scale, upper extremity motor dexterity by box and block test, and upper extremity joint range of motion by goniometer and by a phone application named as physiomaster. after the assessment, participants will be randomly assigned to two groups: open kinetic chain activity group and closed kinetic chain activity group. after performing the exercises, all evaluations will be conducted again. thus, the aim is to understand the immediate effects of two different group exercises on the evaluated parameters.


Eligibility criteria:
inclusion criteria: * stroke diagnosis; * hemiplegia; * subacute\&chronic phase (more than 3 months); * brunnstrom 3-4-5; * unsupported sitting ability; * being volunteer. exclusion criteria: * having botox within the last 6 months; * 4 according to modified ashworth scale; * other neurological diagnosis other than stroke.

Keywords: stroke spasticity dexterity open kinetic chain closed kinetic chain
quantitative assessment of painful diabetic peripheral neuropathy after high frequency spinal cord stimulation

Conditions: Painful Diabetic Neuropathy

Summary: will participants with painful lower extremity diabetic peripheral neuropathy (dpn) that are treated with high frequency spinal cord stimulation (hf10 scs) have improvements in lower extremity peripheral nerve function?

this research study is being conducted to find out if spinal cord stimulation (scs) can improve nerve function. scs is fda approved for the treatment of intractable neuropathic (nerve) pain related to diabetic peripheral neuropathy. with scs a wire is placed in the epidural space and the spinal cord is stimulated to interrupt the pain signal coming from the legs. the spinal cord stimulator is a device similar to a pacemaker (which helps treat abnormal rhythms of the heart). recent studies have suggested that scs with high frequencies can improve nerve function for subjects with painful peripheral neuropathy therefore, the investigators are looking to measure changes in nerve function after scs for treatment of painful diabetic peripheral neuropathy. the purpose of this research is to gather information on the effect of high frequency spinal cord stimulation (hf10) on nerve function with a spinal cord stimulator.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * refractory predominantly lower extremity neuropathic pain for \> 1 year * presence of length dependent peripheral neuropathy on sudomotor testing * completed spinal cord stimulation trial with 40% or greater pain reduction from baseline * failed medication trials or contraindication to gabapentin medications (gabapentin, pregabalin) and/or serotonin/norepinephrine reuptake inhibitors (tricyclic antidepressant (tca) or duloxetine or venlafaxine) * average pain score on a visual analog scale (vas) of ≥ 5 (with 0 representing no pain and 10 the worst pain imaginable) * appropriate surgical candidate for spinal cord stimulator exclusion criteria: * severe autonomic neuropathy as measured by the composite autonomic scoring scale (10 point scale) with a score ≥ 7 * history of sympathectomy * uncontrolled arterial hypertension (systolic blood pressure \>160) * baseline foot tcpo2 \< 10 mmhg to exclude patients with severe peripheral arterial disease * hemoglobin a1c \> 8% * stable opioid regimen with oral morphine equivalent ≥ 100 mg/day * alternative principle cause for peripheral neuropathy or lower extremity neuropathic pain * disruptive psychiatric disorder (screened for during preoperative psychiatric evaluation) * pending litigations * women of child bearing potential unwilling to use contraception or found to be pregnant as part of perioperative screening * patients unable to hold medications that would impact autonomic testing

Keywords: spinal cord stimulation type 2 diabetes
early identification of patients in surgical intensive care with a risk of acute respiratory distress following visceral surgery

Conditions: Digestive Surgery; Urinary Surgery

Summary: today there are few studies in the literature involving patients in an icu following major visceral surgery. there are thus few results about the prognostic value of pulmonary extravascular water in this population of patients, but also the prognostic value of pulmonary extravascular water measured at the bedside using pulmonary ultrasound. in addition, pulmonary ultrasound will be combined with echocardiography to measure left ventricular function (lvef) and to study the profile of the mitral valve to assess filling pressure in patients with immediate post-operative ventilation. this will make it possible to distinguish between increases in pulmonary extravascular water associated with high filling pressure and increased pulmonary water associated with low filling pressure: characteristic of lesional oedema. the aim of this study is to determine the prognostic value of extravascular pulmonary water (pevw) diagnosed using pulmonary ultrasound in patients admitted to an icu following scheduled or emergency visceral surgery in the onset of acute respiratory distress requiring invasive mechanical ventilation, or prolonged post-operative intubation, or non-invasive.


Eligibility criteria:
inclusion criteria: all patients undergoing scheduled or emergency visceral surgery and admitted to an icu following the intervention. exclusion criteria: * chest surgery * asa (american society of anesthesiologists) 4 or more * refusal of the patient * pregnant women * spontaneously-breathing patients
characteristics and outcomes of acute myeloid leukemia (aml) patients treated with oral-azacitidine maintenance therapy in france

Conditions: Acute Myeloid Leukemia (AML)

Summary: the purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of oral azacitidine prescribed as maintenance treatment after frontline treatment or second remission for acute myeloid leukemia in france.


Eligibility criteria:
inclusion criteria: * participants who initiated oral azacitidine maintenance therapy during early access program (eap) in france (january 29, 2021 to july 13, 2022) or during the 6 months post-eap (from july 14, 2022, to january 2014, 2023) inside the marketing authorization label "adult patients with acute myeloid leukaemia (aml) who achieved complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (hsct)." * participants with histologically confirmed diagnosis of de novo aml, or therapy-related aml, or secondary aml * participants who received frontline treatment after diagnosis of aml and achieved complete remission (cr), cr with incomplete blood count recovery (cri), or cr with partial hematology recovery (crh) after one or subsequent lines of therapy in case of relapse * participant is at least 18 years of age at the time of initial diagnosis of aml * participants alive or deceased at the time of data collection * physician has access to the complete medical record for the patient, including any transferred records from other facilities (if applicable); patient's medical record must at least include the following: * date of diagnosis of aml * frontline therapy(ies) received, and treatment start dates * date(s) of first documented evidence of response * oral azacitidine start and (if applicable) stop date * documentation (yes/no) of relapse on oral azacitidine, where applicable * participants who do not object to the data collection exclusion criteria: * participants who initiated maintenance with oral azacitidine after january 14, 2023 * participant who initiated maintenance with oral azacitidine before january 14, 2023, outside of the marketing authorization label

Keywords: acute myeloid leukemia (aml)